MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2200-2006

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

When the physician removed the angiosculpt from the pt, the angiosculpt got hooked onto the guide catheter.In order to remove the angiosculpt, the physician removed the guide wire and guide catheter together and angiosculpt broke in two pieces.

Manufacturer Narrative

(b)(4): the angiosculpt is pending device investigation.It was alleged that the angiosculpt separated in two pieces.This has not been confirmed due to pending device investigation.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer Contact: kent jones ; 5055 brandin court; fremont, CA 94538 ; 5109337904
• MDR Report Key: 4353471
• MDR Text Key: 20017415
• Report Number: 3005462046-2014-00040
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2017
• Device Model Number: 2200-2006
• Device Catalogue Number: 2200-2006
• Device Lot Number: F14070027
• Other Device ID Number: M3702200200610
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F GUIDE CATHETER; 6F INTRODUCER SHEATH; MFR'S UNK: 0.014" GUIDE WIRE
• Patient Age: 71 YR
• Patient Weight: 72